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The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries


News Link 97

EU diplomats agree to 7% biofuels cap 

The US Farm Bill: What implications for Africa? 

The global cotton market has changed: What does it mean for African producers?  

How does the US Farm Bill affect food security in Sub-Saharan Africa? 

World No Tobacco Day 2014: Raise taxes on tobacco, a proven weapon of mass destruction!   

Huge divide over Uganda’s HIV prevention bill 

South African Trade Minister Davies: Election Result May Mean Fast Action On IP Policy  

New EU framework for protection of trade secrets

How the new Global Fund-WHO partnership will work 

WHO Executive Board Wraps Up Post-WHA Work  

Developing Entrepreneurial Spirit in Nigeria 

“We Are Not Job-Seekers, We Are Job-Creators”– Turning Unemployment into Entrepreneurship 

Lagarde Urges Africa to Act on Poverty 

Africa Developing Unified Climate Strategy 

Advancing Global Food Security in the Face of a Changing Climate

Modi’s daunting development  task 

5 Predictions for India’s Development Cooperation Under New Government  

What you may have missed: Narendra Modi’s message to China 

The Latest Health Wonk Review 

For Telehealth Patient Safety Insists Upon An Evolution In Policy

White-washing e società scientifiche 

WHO: update on the Geneva buildings  renovation strategy

World Bank says half of proposed $400 million savings found

World Bank leaders planning staff cuts 

Spare the rod – the biology of poverty and violence

Rapporto Osservasalute 2013. Stato di salute e qualità dell’assistenza nelle regioni italiane 






Radio Vaticana: Intervista a GESPAM

Medicine Salvavita per Tutti, non solo per chi se le può permettere

Oltre la metà  dei 5 miliardi di abitanti nei paesi del sud del mondo conta su meno di due dollari al giorno per la sussistenza, mentre il fenomeno della contraffazione e cattiva qualità  dei prodotti farmaceutici lievita e le medicine salvavita sono vincolate a regimi brevettuali esacerbati da accordi di libero scambio e da politiche governative sbilanciate a favore di €™interessi di monopolio.

Per cercare di €™informare, sensibilizzare e stimolare un dibattito attorno a questi temi è nato GESPAM, acronimo di ‘Geopolitica, Salute Pubblica, Accesso alle Medicine’€™. GESPAM è un ramo operativo di Equilibri, Agenzia Italiana di Geopolitica e Relazioni Internazionali.

Ne parla ai nostri microfoni, Daniele Dionisio, medico infettivologo, membro del Gruppo di Lavoro del Parlamento Europeo ‘€˜Innovation, Access to Medicines and Poverty-Related Diseases’€™ e fondatore di GESPAM: 


News Link 96


The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries


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9 important takeaways from #WHA67 

WHO To Develop Global Action Plan Against Antibiotic Resistance 

World Health Assembly Approves Plan To Strengthen Access To Essential Medicines  

WHO Agrees Plan For Sustainable R&D For Developing Countries; TDR May Host Pooled Fund  

World Health Assembly 23 May 2014 Framework of engagement with non-State actors 

WHO Members Note Reform Progress, Ask For Speedy Implementation   

World Health Assembly Adopts Resolution On Hepatitis; Member States Concerned Over High Prices 

WHA: Experts Discuss Methods For Innovation, Access For MICs

World Health Assembly Approves Resolution On Combatting Tuberculosis  

After anti-gay law, new bill threatens fight against HIV in Uganda 

Modern drug discovery and the fight against NTDs: How can the PDP model enhance and accelerate the R&D process? 

Demonstration Financing: Considerations for a Pilot Pooled international fund for r&d 

Paediatric HIV Treatment Initiative (PHTI) to Spur Innovation and Access to Improve the Lives of Children Living with HIV 

DNDi Receives Support from Norwegian Agency for Development Cooperation for its Research & Development on Sleeping Sickness 

How to feed the world when the new generation doesn’t want to go into farming  

“When the sun is shining, our crops are dying”

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‘Beyond GDP’ is code for anti-prosperity  

Why Jeffrey Sachs matters  

Health Policy Research And Disparities: A Health Affairs Conversation With Lisa Simpson And Darrell Gaskin 

Chile and Costa Rica: Different roads to universal health in Latin America 

8 Facts about China’s Investments in Africa 


The Process of Decentralization in Lebanon: South Beirut Municipalities are Improving Primary Healthcare Services and Integrated Local Welfare

The Lebanese Health care system is very fragmented due to the lack of a public health policy, strategic planning of services and their organizational structures. Now, through a new process of decentralization, South Beirut Municipalities are improving primary healthcare services and integrated local welfare

The Process of Decentralization in Lebanon: South Beirut Municipalities are Improving Primary Healthcare Services and Integrated Local Welfare


by Cinzia Chighine*

 Tuscany Region, International Activities


The conflict between Israel and Lebanon in July 2006 and the internal repercussions in Lebanon have outlined a new political and economic scenario. Moreover, the internal contradictions and the external interference have negatively influenced the Lebanese economic growth.

According to the Social Action Plan of the Ministry of Social Affairs, the Lebanese Government Budget, historically oriented to multi-year strategies in the Social and Educational field,  has been totally re-planned in order to meet the new Emergency.

Sustained political and security instability have further widened the fiscal deficit and capped Lebanon’€™s GDP growth near 1 percent in 2014, as the International Institute of Finance declared in a revised assessment of the country’€™s economic situation.

The current scenario shows  four main challenges that will weigh on the Lebanese economic performance:  the Presidential election during the year, the formation of a new Government in Lebanon and an escalation of the civil war in Syria, while the frequency of violent incidents in Lebanon has increased.

A Presidential Election was held in Lebanon on 23rd April 2014. Since no candidate reached a two-thirds majority vote, a second round had been scheduled for April 30, a third round for May 15, and a fourth round for May 22. Due to lack of quorum the elections had been aborted.

The Syrians fled to Lebanon  since the outbreak of the civil war are more than one million and they are causing a strong impact on the economy of the Country, for which the United Nations are now asking for urgent international aid. By now the number of refugees, half of whom are children, is equivalent to a quarter of the Lebanese population and according to the United Nations High Commissioner for Refugees, Antònio Guterres, the flow is accelerating.

Today Lebanon ranks 38 out of 135 countries concerning the Poverty Index and it is in 78th place out of 179 as concerning the Human Development Index. Twenty-two percent  of the Lebanese Population is under 15 years and 12% over 60. Life Expectancy is around 73 years. Child Mortality Rate is around 18/1000, while the Maternal Mortality Rate is around 25 per 100,000 live births (2013).

Even in the Health sector there are some critical aspects that represent significant challenges for the public insurance system. The per capita public expenditure in Health services is out of a total of $ 235.8 while the total per capita Health spending is  $ 923 (2013). Public expenditure on total Health expenditure is 5.8% (data from WHO 2013).

In terms of chronic diseases, there is a prevalence of diabetes (12%), hypertension (32%) and obesity (29% over 20 years).

The Sustainable Health system is normally guaranteed by the repayment for each performance initially covered by the public insurance. The costs are aggravated by the repetition of single performances, by some inappropriateness of care pathways and by inappropriate admissions. Considering these anomalies, the overall costs of the Health system -taking into account the overall volume of the performance- are particularly high: the total health expenditure is around 13% of Lebanese GDP with the unfavorable balance between cost/efficiency and cost/benefit.

The poor offer of Basic Health Services and the not always appropriate prevention, such as the lack of continuity of care and inequity of access to them, are important critical points of the system.

The setting of the private Health and Education system does not favor the widespread access to basic rights for a broad segment of the population.

The Lebanese Health Service consists of 90% by individuals and private facilities structures that deliver performances in hospitals, clinics or in local specialized districts in which they operate.

The specialist medical visits, hospitalizations, laboratory examinations, rehabilitation services are reimbursed by 80 % by the public or private insurance companies. However, about 50% of the general population is excluded by the insurance system. Only those who have a job in the private or public sector enjoy the right to the mandatory health insurance.

Lebanese population loses the insurance coverage with the attainment of the retirement age, except for a few and privileged categories of people. The State reimburses only the costs of first aid hospitalization to them, according to no more adequate rates, because they have been agreed in the past.

The Lebanese Health care system is very fragmented due to the lack of a public health policy, strategic planning of services and their organizational structures. Accordingly, an excessive commercialization of health services increases the gap between rich and poor people.

According to Ministry of Public Health (MoPH) database, the insurance coverage in Lebanon is the following:

Social Security – “€œDaman”€ 26.1%

Cooperative of Government employees 5.5%

Army 9.1%

Security facilities 2.2%

Private insurance 8.8%

Ministry of Public Health 48.3%

About 50% of the Lebanese  population (unemployed people and almost all of the elderly population) is excluded from the public or private insurance system. According to the National Health Program of Lebanese MoPH, the State reimburses only the costs of hospitalization and the first aid service to these citizens. A partial role in filling gaps is covered by various religious congregations and some local NGOs to whom a part of the poor population is referring to.

According to MoPH Database, in addition to the public Health structures managed by the MoPH (nr. 15 units), by MoPH/NGOs and Municipality (nr.14 units), by Ministry of Social Affairs (nr. 3 unit), by NGOs (nr. 53 units) and by the Municipality itself (nr. 1 unit), there are about 800 dispensaries, managed by Lebanese NGOs, to whom only 15% of the population, in large part not covered by insurance, is addressed.

The network of the dispensaries – created as a quick  response to post-war emergencies – is suffering from the lack of minimum quality standards and professional skills in the offered services, and it would require a rethinking in a perspective of public reorganization of basic services.

In 2007 the rethinking of the concept and the prerogatives of dispensaries started in several municipalities in the southern suburbs of Beirut, among the areas most affected by the conflict. The South Beirut dispensaries have been transformed into Primary Care Centers (PHCC) and one of these centers is being accredited by the MoPH.

The Southern Suburbs of Beirut -called Dahiye – include eight municipalities, some of which have been particularly hardly hit by Israeli bombing in 2006. During the conflict many people from southern Lebanon have settled in these suburbs often occupying the skeletons of buildings destroyed by the civil war and never rebuilt.

The Social and Health care services offered to the local population in these areas are extremely limited and not incorporated into the regular activities of the municipalities.

The Lebanese administrative decentralization process -despite an ongoing reform deeply desired by the Lebanese Chairman, in order to incorporate the  recommendations of the Ta’if Agreement (1989) – is  essentially quite new.

The local government is represented by the Municipalities, as the Districts (Mohafazat in Arabic) don’€™t’ have political power in terms of delivery of services to citizens and are not beneficiaries of the financial resources by the central government.

The Lebanese Municipalities -as revealed by a study conducted by the “€œCenter for Administrative Innovation in the Euro-Mediterranean region” €(CAIMED)- don’t have developed relationships with the citizens they are dealing with. The Municipalities provide basic services i.e. Tax collection, without actually establishing links with the people.

Recently, some Municipalities have joined together in  “€œUnion of Municipalities”€.

The “€œOffice of the Minister of State for Administrative Reform”€ (OMSAR) highlights – among the main difficulties it has to deal with in his role as a facilitator for the effective application of the administrative law reform – the lack of support by local governments as they are not ready to change. Actually, the forms of cooperation between different Lebanese actors are limited by the legacy of the civil war.

Lebanon has been the scene of many conflicts, mainly due to its complex social, religious and political composition.

The repercussions of these events fall on the Lebanese people who are still  living situations characterized by poverty, unemployment, lack of opportunities, conflicts and widespread violence at the local level.

The national political instability has not activated the processes of decentralization. The municipalities are representative bodies with small margin of direct intervention on the needs of the population.

The Issue of Health is a strategic factor to strengthen, through the implementation of operational tools, the governance of the territories, exchanges and more dialectical confrontation among the Government Institutions. At the same time , Health Policies are influenced by environmental, economic, social and political issues, that directly affect the community. The Health integrated approach is therefore a “€œroadway”€ for local authorities to strengthen  their role thus gaining its political-administrative function.

In the framework of the UNDP ART Gold program, the Region of Tuscany supports the network among Social Offices of the Municipalities, offices for local development (LEDA) and the Centers for Primary Care (PHCCs), particularly in the suburbs of South Beirut, in order to reinforce, in accordance with the MoPH, the local health systems in areas affected by the now highly migratory flow of Syrian refugees.

The initiative aims to support the general goal of the administrative decentralization process. The PHCCs will reinforce the role of local authorities as public providers in the Municipalities of Al Mreyjeh, Al Chiah and Furn Al Chebbak,  Haret Hreik, Ghobeiry, Tyre, North Akkar Region, in accordance with the recommendations of the Ministry of Health in order to adopt a new approach to Primary Care through the Social Offices.

The experience has allowed to break the fragmentary in the Lebanese Health Sector, improving the population’s access to basic services through the implementation of a modern integrated system of Primary Care.

The network of PHCCs is able to generate operational synergies with the Education system through permanent programs of Education and Health promotion, Health education , prevention and care.

Particularly, the Region of Zgharta, deeply affected by the emergence of the Syrian refugee population is involving PHCCs in a new integrated approach to the Local Welfare.


 *Cinzia Chighine, born in Viareggio (Italy) in 1974, has been professionally active as aid-worker in Africa and Middle East area for a decade. She works now in Florence as a staff member of Tuscany Region’€™s International Activities Department

News Link 95


The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries


News Link 95

IP, R&D Among Issues In Packed Agenda Of 2014 World Health Assembly  

World Health Assembly 2014 — 3 things to look out for in Geneva 

People’s Health Movement Commentary on the Agenda of the 67th World Health Assembly  

WHO: Increasing access to HIV treatment  in middle-income countries. Key data on prices, regulatory status, tariffs and the intellectual property situation

New Initiative To Address Lack Of Paediatric-Specific HIV Treatments

EU and UNICEF launch ‘Voices of Children in Emergencies’ joint campaign  

EU more than doubles vaccine aid as Gavi launches appeal   

No Excuse Left but Biotech: Will the United States start a smallpox threat creation program? 

Statement of the Joint PAS/PASS Workshop on Sustainable Humanity, Sustainable Nature: Our Responsibility 

EU holds public consultations on TTIP investment chapter 

STOP TTIP Ribaltare l’Europa dei mercati, costruire l’Europa dei diritti 

EPO Internal Strife Spills Over Into European Parliament, Human Rights Court  

Budget 2014: The end of an aid era? 

The Potential Power of Social Crowdfunding   

Il caso del vaccino anti-Aids: Interrogazione al ministro Lorenzin 

Human Rights Organizations Condemn Ugandan Law, Bill Criminalizing Homosexuality, HIV Transmission  

The Power of Procurement: Public Purchasing in the Service of Realizing the Right to Food     

Diseguaglianze, povertà alimentare e salute  

International Seed Treaty Brainstorming For Sustainability   

Special Report – Students To Universities: “We Have A Drug Problem”    

Where Are Chinese Investments in Africa Headed? 

How Climate Change Will Destroy Your Country’s Credit Rating 



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The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries 


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La Tassa europea sulle Transazioni Finanziarie per la lotta alla povertà e al cambiamento climatico

Department of Homeland Security IP Seizure Statistics Reveal Misplaced Priorities or Misrepresentation  

Panel: Good Governance Is Key To Achieving Global Health Goals

‘Coordinate, coordinate, coordinate’


How Tim Evans will lead World Bank efforts toward UHC 

China to Earmark over Half of Foreign Aid for Africa

China  to build  new East Africa  railway  line   

How much agricultural land is China actually grabbing in Africa?

New Chinese investment fund aims to rival World Bank and ADB 

What John Kerry Accomplished (and What He Did Not) in Africa   

British aid and the return of the trickle-down myth  

Shake-up under way in global drugs policy  

FAO, OECD: Food Security Key to G-20 Growth Goals 

Oxfam: German food project ‘ignores subsistence farmers’   

Growth  in  Africa  undermined  by  rapidly  increasing  inequality    

EU’s Nagoya Protocol Ratification: How It Works 

Issues Of Overuse In Health Care 

An Urgent Call to Finish the Job and End Polio 

What Works in Malaria: Part 2  

Epidemiology of Obstetric Fistula in Kassala, Eastern Sudan 


Pharmaceutical Genocide: "India in the Crosshairs"

Hiding behind patents, Pharma has become immune to criticism knowing from previous attempts, no one has the ability to force change.  Along the way, Pharma has developed a powerful constituency among politicians who often use prepared cliches to equate challenges to high prices as a threat to democracy

Pharmaceutical Genocide

“€œIndia In the Crosshairs”€

History, Discussion and Commentary

by William F. Haddad*

Chairman/CEO of Biogenerics, New York


More people die and suffer each day in the poor and developing nations of the world from the war waged on the availability of affordable medicines than die in classic wars.  The “€œmedicines war” – unlike other wars – never ends.  Its victims include men, women and children, born and unborn.

Year after year, millions suffer and die needlessly.

There are no street demonstrations, or crowds surrounding the offices of those who are responsible. There are few editorials or news stories systematically reporting this brutal, silent war.  There is no chorus of outraged politicians.

And there are no “€œScrooges”€ who are forced by their conscience to see their victims suffer and die.  Most of those perpetuating this war are honored by their societies and their secret, the truth, is disguised.

For almost all of these untreated diseases there is a safe, effective, regulated medical clone that is affordable and can be readily available. And, waiting on the sidelines, is a mature and regulated industry to legally clone and manufacture them.

Yet, Third World nations, periodically ravaged by pandemics and crippling illnesses are denied access to essential medicines because, bluntly, access is controlled by the monopolies of multinational pharmaceutical companies (Pharma).  If medicines do become available, they are almost uniformly unaffordable.  When the AIDS pandemic spread to 36,000,000 persons in Third World nations, only 4,000 persons could afford the life-prolonging treatment of $12,000 a year. No one doubted the others would die.

India provides most of the affordable and essential medicines in Third World nations but that success is again being seriously challenged by a coalition led by the U.S. government and Pharma and pursued in an official public investigation.

Recently, a decision by India’€™s Supreme Court, after seven years of litigation, denied a patent to a multinational pharmaceutical company because was a virtual copy of an old existing patent and was not “€œinnovative”€ according to the Indian Patents laws.

In the same time frame, India granted a “€œcompulsory license”€ to a generic company for another cancer medicine because the brand price was “€œexcessive”€ and there was no local manufacture.

Many nations reserve these rights when awarding patents.

These legal judgments stunned the international Pharma companies and sent them running to their strongest ally, the United States where a formal investigation is currently underway. Knowledgeable observers expect the usual result: threats of trade penalties for India.

Unlike previous challenges to Pharma’€™s monopolistic control, it now appears India is determined to defend its rights under international law to manufacture and market essential medicines for its own use and for sale in the poor and developing nations of the world. Political pressures and “€œvisits”€ by ranking American diplomats   failed to “€œpersuade”€ India to capitulate to Pharma’€™s demands.

India’€™s rights are guaranteed by a unanimous vote of the World Trade Organization (WTO).  Under the original “€œDoha Agreement”€ and “€œTRIPS”€ (Trade Related Aspects of International Rights), poor and developing nations lacking medicines in a medical crisis have the absolute right to manufacture or import them, bypassing patents and other restrictions.

Generic companies in India have always responded by providing safe, effective and affordable medicines when the barriers no longer prevent their importation.

But, over time, commercial greed left that right in tatters. Most essential medicines are either unavailable or unaffordable in Third World nations. The result was predictable: people suffered and died.

Suddenly, all that changed.

The AIDS Pandemic

In the late 1990s, when the extent of the AIDS pandemic in Sub-Saharan Africa was recognized, only 4,000 out of over 30 million afflicted could afford treatment although the medicines to keep AIDS victims alive was readily available in Europe and the United States.  The reason was not difficult to understand. The three multinational pharmaceutical companies manufacturing the AIDS medicines sold them collectively for $ 12.000 to $ 15,000 per person per year in western nations and turned a deaf ear to urgent pleas to provide the medicines at an affordable price in the third world and developing countries.

A few executives in private meetings had decided who would live and who would die and the combined influence of the world’€™s non-governmental and humanitarian organizations, churches, courageous politicians and others could not change that decision. Lacking affordable medicines, millions in the Third World died slow and agonizing deaths.

As history will report in years to come, there was one scientist not intimidated by Pharma’s power and propaganda or by the inevitable surrender of nations unable to obtain affordable AIDS medicines.

Dr. Yusuf Hamied, a scientist and managing Director of an Indian company, Cipla, Ltd. whose generic products were used in the United States and nations around the world, answered his critics by creating a generic AIDS medical clone combining  the medicines from three different companies into one tablet taken twice a day, one in the morning and one in the evening, the regime needed to enhance widespread use in the Third World, and reduced the cost to below a dollar-a-day.

For the millions on the highway to death, this “€œtriple”€ called “€œTriomune”€ became the affordable medicine that converted a certain death sentence into a renewal of life.

The generic clone was approved for use in India, followed by approval for wide and extensive use by the World Health Organization (WHO) and then by the U.S. Food and Drug Administration, widely regarded as the world’s strictest regulatory authority.

Even with these universal approvals in place, Pharma was able to delay its widespread use for three more years.  What was being hailed as a major scientific breakthrough was trumped by Pharma’€™s control of the political process.

I joined Dr. Hamied in the year 2000, as he courageously sought to remove the political wall preventing use of the approved and affordable AIDS medicines.

Pharma quickly learned it was not a fight he would abandon.

For a moment, please, use your “€œmind’€™s eye”€ and join me as I visited hospitals in Africa and elsewhere and share with me a persistent memory of hospital hallways filled with patients lying silently on thin mats waiting to die, a sight made all the worse because in my pocket I had a sample of an affordable medical clone that could restore them to life, a medicine the multinational pharmaceutical companies would not allow physicians to use. There are no words in my vocabulary to describe the lingering pain of watching people die when you knew they could live.

After more than three years of worldwide political struggle, only one hurdle remained blocking use of the generic AIDS medicine, a legal action initiated in a South African court by thirty-eight multinational pharmaceutical companies to prevent the sale of generic medicines in Africa, depriving AIDS victims of their chance to live.

Worldwide, we fanned the flame of a growing awareness that the affordable AIDS clone had the potential for keeping millions of AIDS victims alive.  The mounting criticism became intolerable, finally forcing brand companies to abandon their legal action in South Africa.

Within days, Dr. Hamied, joined by two executives from Doctors Without Borders, flew to WHO in Geneva where we urged a “€œone-stop”€ worldwide approval process be created to replace the required nation-by-nation procedure then in place. WHO’€™s approval and departure from tradition could quickly return the dying to life and for many, preserve their families and prevent children from returning to the villages their parents left in search of hope.

Under the determined guidance of a talented, “€œno nonsense”€ WHO scientist, Dr. Lembit Rago, the one-stop worldwide regulatory approval…a first…was developed and accepted by recipient nations and shortly thereafter was required for AIDS financing.  In months, the system was not only in place but the doors were wide open to keep millions alive.

Only the United States objected and insisted on imposing an additional approval by the Food and Drug Administration for all AIDS medicines financed by their monies although the generic AIDS clone could not be used in the United States, delaying much needed support for three additional years, the time required for Cipla to have its generic products approved without change by the FDA. In the interim only the high priced brands were financed with U.S. funds, an unnecessary tragedy as millions of lives could have been saved in this period by WHO approved drugs available at 1 to 2% of the USA pricing.  With an approved FDA product, more than a dozen Indian companies submitted their products insuring continuous availability.

Today more than 8,000,000 people in Third World countries use the generic AIDS clone at a cost of under one hundred dollars a year.

One basic question lingers: who was responsible for allowing poor people to suffer and die in poor countries when affordable medicines were readily available?  No Pharma company, no politician, no nation should have the right to decide who lives and who dies in a pandemic.

One practical and commercial solution is on the horizon, “€œnegotiated pricing” between brand and generic companies in Third World markets.  If Pharma seriously contemplates a solution, one pragmatic solution is on the table: adopt the original stipulations of the DOHA declaration and allow their patents to be used with payment of a nominal royalty.

Silent Voices

For many years, advocates for AIDS treatment in Third World countries turned to the United Nations for help. There, early on, the late Richard Hollbroke, as U.S. Ambassador to the U.N., surprised the world by urging the Security Council, usually the forum for issues of war and peace, to add the human and political consequences of the AIDS pandemic to their agenda. Although his unique intervention won the Council’€™s support and was praised diplomatically and in the media many years passed until the U.N. finally convened a Conference on how to make AIDS medicines available but also decided generic companies could not attend the meeting.

Efforts to include the generic industry failed. On my last call I was bluntly told “€œwe are looking for a solution”€ and I was asked, not politely, not to call again.

Their Conference ended with a press conference but without a solution and the unaffordable cost of AIDS medicines was not changed.

Again, in Panama, after I gave a keynote speech to the Health Ministers of Latin American companies, I was pulled aside by the Panamanian Cabinet Minister who had organized the Conference.  In a voice that raged from anger to fury, he told me to leave the Conference. Why? Pharma’€™s observers were angry.

At a later date, Cabinet Ministers from all Latin American companies met to find an affordable solution to their AIDS crisis. Only one Brand Company with a non-AIDS interest remained after the Ministers explained they might authorize joint purchases in an effort to reduce the cost. They eventually decided $250, not $12,000 a year, would be appropriate.

India in the Crosshairs

From the first days of competition in the pharmaceutical industry, India has led the world in providing safe and affordable generic clones of branded medicines not only for the United States but for the poor and developing nations.

Literally, as “€œthe pharmacy of the world”€ Indian generic companies provide approximately forty percent of the medicines used in the United States and virtually all the affordable medicines sold in the Third World.

Once again, that tradition is facing determined political resistance by the multinational pharmaceutical companies and their legion of Congressional and business allies in the United States.  India, literally, is currently in the cross-hairs of a well-financed assault.

As a first-hand witness to this struggle, I believe Pharma wants nothing less than to strangle and annihilate generic competition in the Third World.  Pharma argues, falsely but effectively, that lower prices for medicines in the Third World will challenge the high cost of medicines in monopolized western nations and as a result, the industry will not have the financing to find new cures for diseases.

That argument is not only devious, but false, and remains the classic Pharma answer to almost all complaints. The hard, inescapable fact is that higher prices are not “€œset asides”€ for discovery or development of new medicines, but to enhance the value of brand-name stocks and to provide generous dividends to its stock holders.

Exploring for the truth of their classic response reveals another story: multinational pharmaceutical companies are historically and currently the most profitable industry in the world although many of their “€œdiscoveries”€ are rooted in Government research. The U.S. National Institutes of Health (NIH) spends about $31 billion a year on biomedical research.

Pharma companies, however, must be credited with converting some of this research into important medicines although their products too often focus on similar clusters of illness.  Peter Maybarduk, the program director of Public Citizen’€™s Global Access to Medicines, in a fascinating unwinding of Pharma’€™s alibis for monopoly pricing, noted:

“€œMonopoly pricing, in the case of many diseases, has led to a morally repugnant status quo in which many people die for lack of access to existing medicines. Unfortunately, patent holders frequently believe (rightly or wrongly) that they stand to make the greatest profits selling at very high prices to the few rather than at affordable prices to the many. This is certainly the case for industry pricing of several cancer medicines at issue in India (see below). In developing countries, including India and countries which rely on affordable Indian generics, these pricing practices lead to preventable suffering and death.”

The multinational pharmaceutical companies, worldwide, are not competing in a free market, but one sustained by monopolistic control, political power and intrigue and at the apex of their power is the twenty-year patent that limits competition in developed nations.  In the Third World Pharma is currently attempting to enhance its unofficial monopolies with patent protection but to insure control, Pharma must also suppress India’€™s ability and legal willingness to provide affordable medicines. That campaign is already underway.

India In Pharma’€™s Crosshairs

As noted earlier Pharma and its allies, including those in the Obama Administration, the U.S. Congress, the National Association of Manufacturers and the US Chamber of Commerce have now joined forces to prevent India from providing affordable medicines for Third World nations.

Until 1995, Indian law permitted generic companies to manufacture clones of branded medicines using procedures that did not violate patents, enabling affordable medicines to be sold both in India and exported to Third World countries.

In that year, with Pharma’€™s political and financial support, and at the urging of western nations led by the United States, India adopted a Western-style, twenty year patent law that will eventually terminate India’€™s ability to provide affordable new medicines for the poor and developing nations of the world. The consequences are understood, people will suffer and die because the medicines are unaffordable and potentially affordable clones are banned.

Pharma’€™s achievement did not evoke outrage in the West or in most of the Third World where it was accepted as inevitable. Supporters hailed the change as “€œa victory for free enterprise”€.  Others called it a “€œdeath sentence”€ for competition and affordable medicines.

For decades, as one writer noted, “€œIndia was a burr under Pharma’€™s saddle”€.  The multinational pharmaceutical companies believed the new law has removed that burr.

Legally, India’€™s rights are guaranteed by the World Trade Organization.

The World Trade Organization and TRIPS

The right of poor and developing nations to manufacture or import medicines in a crisis is guaranteed by the World Trade Organization (WTO) in its TRIPS Agreement (Trade Related Aspects of Intellectual Property Rights) and by the so-called “€œDoha Agreement”€ that unambiguously  allows a nation to be released from any restrictions, including patents, in order to meet pharmaceutical needs.

India Urgently Needs Help

Currently, Pharma has once again turned to the United States to prevent India from offering affordable prices for generic medicines in Third World nations. This time their target is India’€™s Supreme Court.

In late 2013, after seven years of study, India’€™s highest Court ruled against granting market exclusivity for “€œGleevac”€, a life-saving cancer medicine manufactured by Novartis. The medicine, the Court ruled, did not deserve a patent because it did not meet the basic requirement for a patent protection, innovation.

That decision brought into the open a classic, often used worldwide Pharma tactic…”€œtrick”€ is a more accurate word….to extend patent life of a product whose patent is expiring. Their manipulation of the law is called “€œEvergreening”€, the process frequently used to seek additional patent life for a product after its exclusivity ends.

In an attempt to obtain a new seventeen year patent, Pharma companies will add new ingredients to an existing product and apply for a new patent that is more frequently granted than denied.  The new product becomes the subject of a massive advertising campaign to physicians and others promoting claims that the “€œnew”€ product offers unique medical advantages.

The sole reason for the new patent is to maintain market share by blocking generic competition.

In the “€œGleevac”€ decision, the Supreme Court ruled, the added ingredients did not make the medicine “€œinnovative”€ and therefore not eligible for a new patent.

About the same time, exercising its established legal prerogative, India issued a “€œcompulsory license”€ (CP)  to an Indian company to manufacture and market “€œNexavar”€,  another cancer drug, one controlled by Bayer at a price that was unaffordable in India.

Use of a compulsory license mandate is not exclusive to India. A dozen nations have also awarded similar licenses to compensate for high prices on pharmaceuticals and other products.

In retaliation, Pharma and their allies demanded the U.S. Government and President Barack Obama classify India as a “€œPriority Foreign Country”€ the worst sanction possible, one that can result in a ban on the importation of India products into the United States.

The investigation was also requested by two powerful and influential Congressional Committees, Senate Finance, and the House Committee on Ways and Means.

The U.S. International Trade Commission (ITC) was quick to respond and held its first meeting last month and another is planned for next month.  The Commission promised to deliver recommendations from its “€œinvestigations”€ to the Congressional Committees by November 30, 2014.

The Commission is expected to rule against India.

The “€œThousand Dollar Pill”€

The high cost of cancer medications has left a raw nerve among patients and their physicians and the recent introduction of “€œSofosbuvir”€ became the straw that broke the camel’€™s back.

When taken with existing medicines “€œSofosbuvir”€ has the potential of curing “€œHepatitis C”€ a disease that afflicts 150,000,000 persons worldwide. But who will be able to afford it?  “€œSofosbuvir”€  will cost $84,000 for a twelve week treatment or one thousand dollars a pill.

WHO, in a rare statement on the cost of medicine said the new treatment “€œis unaffordable to most patients in need (and the) challenge now is to insure that everyone who needs these drugs can access them.”

The unanswered question remains “€œhow”€?  Hiding behind patents, Pharma has become immune to criticism knowing from previous attempts, no one has the ability to force change.  Along the way, Pharma has developed a powerful constituency among politicians who often use prepared cliches to equate challenges to high prices as a threat to democracy.

What’€™s Next?

Medically, in Third World countries, the shortage or absence of pediatric and adult cancer medicines calls out for immediate generic intervention. It is a problem generic companies and academic cancer scientists can solve. All the pieces of the puzzle are legally in place.

As a first step along the way, the relevant medical and scientific community should be assembled to create a pragmatic, “€œfirst step”€ formulary of pediatric and adult cancer drugs. The meeting should also include companies interested in manufacturing affordable medicines.

A distinguished “€œkeynote”€ speaker…and there are several now working with WHO… who could detail how Third World nations are legally entitled under TRIPS to either manufacture or import essential medicines, e.g., pediatric and adult cancer drugs.

With the legal rights explained, a panel of nations already using TRIPS or other rights to manufacture or import essential medicines can detail their practical experience. Brazil, Thailand and half a dozen other nations have already successfully navigated their potential to provide essential medicines.

The obvious forum is the World Health Organization in Geneva.

An updated list of essential cancer medicines should also be maintained by WHO.

Although it is possible, but not likely, WHO itself could urge Third World Nations to exercise their rights.

I am rather confident independent financing for the WHO meeting can be found.

Although I am of that clique that believes too many Conferences are held without accomplishing their stated goals, I believe the lack of available and affordable cancer medicines is pragmatic and do-able

The goal of a continuing flow of affordable medicines is not pointless idealism but with men like Dr. Hamied and Dr. Rago, success can be just around the corner if we are willing to take the time to find it.

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* Haddad Bio

The media refers to Bill Haddad as “€œthe father of the modern generic industry”€ for initiating and negotiating “€œHatch-Waxman”€, the Drug Price and Patent Restoration Act that opened the closed door for generic competition in the United States. He led the Generic Industry Association for a dozen years and was CEO of Schein Pharmaceutical.  He is currently Chairman/CEO of Biogenerics.  He has worked closely with Dr. Hamied of Cipla, Ltd. to lower the cost of AIDS medicines.

Mr. Haddad won a dozen awards as an investigative reporter for the New York Post and the New York Herald Tribune. At the Tribune he exposed the cartel that controlled prices for tetracycline worldwide and Pfizer was eventually fined $200,000,000.  At the Post he was a finalist for the Pulitzer Prize for exposing corruption in New York City’€™s slum clearance program and providing the evidence to send a high ranking public official to prison. At the Herald Tribune he located the secret papers exposing a world cartel controlling uranium prices that led to a Congressional investigation.

He was an assistant to Senator Estes Kefauver and later to Robert Kennedy and served as Inspector General of both the U.S. Peace Corps and the national poverty program. 

He was a Member of the New York City Board of Education.

News Link 93


The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries


News Link 93

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